Valleylab E2781R-28ASPRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884524000701), received between Sep 6, 2016 and Mar 3, 2021 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Melted” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S ELECTRODE PART AT THE TIP BROKE OFF HALFWAY AND FELL INTO THE ABDOMINAL CAVITY. ALL PARTS WERE RETRIEVED. REPLACED WITH A NEW DEVICE AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403774 ↗
• MalfunctionDec 15, 2020Break; Melted; Self-Activation or Keying; Break; Melted; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING A LAP LOW ANTERIOR RESECTION PROCEDURE, THE SHAFT PART OF THE DEVICE WAS MELTED, AND WAS CRACKED IN THE COURSE OF REPETITIVE USE. IT WAS NOT DISENGAGED, JUST DAMAGED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11012995 ↗
• MalfunctionNov 30, 2020Melted; Self-Activation or Keying; Electrical Shorting; Melted; Self-Activation or Keying; Electrical Shorting

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCTECTOMY, DURING THE PART AROUND THE TIP OF DEVICE WAS FOUND TO BE MELTED IN ABOUT 10 MINUTES AFTER THE START. THERE WAS NO SIMILAR EXPERIENCE SO FAR. WHEN THEY CHECKED IT WITH THE CURRENT LEAKAGE CHECKER OWNED BY THE HOSPITAL AFTER THE OPERATION, THEY CONFIRMED THAT THERE WAS CURRENT LEAKAGE FROM THE MELTED PART. ALTHOUGH THE SALES REP COULD NOT CONFIRM WITH THE SURGEON DIRECTLY, THE ABOVE DETAILS WAS CONFIRMED WITH THE NURSE IN CHARGE OF SURGICAL DEPARTMENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE MEDTRONIC INITIAL EVALUATION FOUND THAT THE TROUBLESHOOTING FOUND THE MELTED AREA FAILED HIPOT TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10919494 ↗
• MalfunctionAug 5, 2020Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, LAPAROSCOPIC RECTUM, THE CURRENT LEAKAGE OCCURRED FROM THE WATER HOLE OF THE TIP. WHEN THE TISSUE HIT THE SIDE HOLE (WATER SUPPLY HOLE), IT BURNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: Burn(s)

  MAUDE report 10370311 ↗
• MalfunctionJun 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCTECTOMY, THE SPATULA AT THE TIP CAME OFF AND WAS DETACHED. NOTHING FELL INTO THE PATIENT'S CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8742982 ↗
• MalfunctionNov 8, 2018Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY, THERE WAS NO ACTIVATION FROM THE TIP OF THE DEVICE, ALTHOUGH THERE WAS ACTIVATION OF THE TISSUE FROM THE BLACK INSULATED PART WHICH TOUCHED THE TISSUE WHICH THE INSULATION WAS MELTED NEAR THE TIP OF THE SHAFT. NOTHING FELL INTO THE PATIENT'S CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8050952 ↗
• MalfunctionOct 18, 2018Melted; Melted

  ACCORDING TO THE REPORTER, DURING SIGMOIDECTOMY, ABOUT 5 HOURS LATER, POWER OUTPUT WAS DISTRIBUTED FROM THE SHAFT ABOUT 1CM FROM THE DISTAL END, AND THE SHAFT GOT MELTED. THE NEW DEVICE WAS OPENED, BUT THE ISSUE WAS DUPLICATED WITHIN AN HOUR. THE NEW DEVICE WAS OPENED AGAIN AND IT WORKED FINE. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7978661 ↗
• MalfunctionOct 4, 2018Melted; Melted

  ACCORDING TO THE REPORTER, DURING SIGMOIDECTOMY, ABOUT 5 HOURS LATER, POWER OUTPUT WAS DISTRIBUTED FROM THE SHAFT ABOUT 1CM FROM THE DISTAL END, AND THE SHAFT GOT MELTED. THE NEW DEVICE WAS OPENED, BUT THE ISSUE WAS DUPLICATED WITHIN AN HOUR. THE NEW DEVICE WAS OPENED AGAIN AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7936414 ↗
• MalfunctionAug 24, 2018Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC OOPHORECTOMY AND SALPINGECTOMY, THE CONNECTION PART BETWEEN THE ELECTRODE AND PENCIL WAS LOOSE AND IT WOULD COME OUT. THE SURGEON TRIED TIGHTENING THE CONNECTION, BUT THE LOOSENESS DID NOT CHANGE. ANOTHER SIMILAR DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NOTHING FELL INTO PATIENT'S CAVITY. SURGICAL TIME WAS NOT EXTENDED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813163 ↗
• MalfunctionAug 13, 2018Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING LOW ANTERIOR RESECTION, ABOUT 2 HOURS LATER, THE ELECTRODE TIP WAS FOUND MISSING. THE BROKEN TIP WAS LOCATED INSIDE THE CAVITY, AND IT WAS REMOVED. A DEVICE DID NOT SEEM TO BE DIFFERENT FROM USUAL. NEW DEVICE WAS USED TO CONTINUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7777146 ↗
• MalfunctionJul 27, 2018Break; Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE ELECTRODE WORKED FINE IN THE BEGINNING BUT THEN SUDDENLY THE ELECTRODE TIP BROKE AND PIECE FELL INTO PATIENT'S CAVITY. THE PIECE WAS REMOVED FROM THE CAVITY. NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7728417 ↗
• MalfunctionApr 24, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOWER ANTERIOR RESECTION, THE ELECTRODE BROKE. THE DEVICE WAS MAINLY USED FOR CUTTING DURING DISSECTION OF LIGAMENT AND LAYERS. FOR CONTROLLING BLEEDING, SOFT COAGULATION MODE WAS USED WITH OPTI4. THE ISSUE WAS NOTICED 2 HOURS LATER, DURING THE PROCEDURE WHEN THE OPTI4 WAS PLACED ON AN INSTRUMENT TRAY AFTER USE, AND THE ELECTRODE TIP WAS FOUND DISENGAGED FROM THE SHAFT AND FELL ON THE TRAY. THE DEVICE WAS NOT IN CONTACT WITH OTHER DEVICES, OR EXCESS LOAD WAS APPLIED TO THE ELECTRODE TIP. A NEW DEVICE WAS OPENED TO CONTINUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454912 ↗
• MalfunctionNov 6, 2017Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT DURING AN LOW ANTERIOR RESECTION (LAR) PROCEDURE, ELECTRIC LEAKAGE OCCURRED NEAR THE ASPIRATION HOLES (ASP). A NEW DEVICE WAS OPENED BUT ALSO HAD ELECTRICAL LEAKAGE WITHIN ONE HOUR OF USE. A NEW DEVICE WAS OPENED AGAIN TO CONTINUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7004714 ↗
• MalfunctionNov 6, 2017Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT DURING AN LOW ANTERIOR RESECTION (LAR) PROCEDURE, ELECTRIC LEAKAGE OCCURRED NEAR THE ASPIRATION HOLES (ASP). A NEW DEVICE WAS OPENED BUT ALSO HAD ELECTRICAL LEAKAGE WITHIN ONE HOUR OF USE. A NEW DEVICE WAS OPENED AGAIN TO CONTINUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7004692 ↗
• MalfunctionAug 16, 2017Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, ENERGY EMITTED FROM THE TIP OF THE SHAFT INSTEAD OF THE SPATULA WHEN ACTIVATED NEAR THE URINARY TRACT. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. NO PATIENT INJURY OCCURRED. DURING MEDTRONIC'S INITIAL EVALUATION OF THE RECEIVED DEVICE, IT WAS FOUND THAT PART OF THE INSULATION AROUND THE ASPIRATION HOLES WAS MELTED. THE DEVICE ALSO FAILED HIPOT TESTING AROUND THE MELTED INSULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6799303 ↗
• MalfunctionAug 16, 2017Arcing; Arcing

  THE CUSTOMER REPORTED THAT THE DEVICE WAS SPARKING. NO PATIENT INJURY OCCURRED AND A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. DURING MEDTRONIC'S INITIAL EVALUATION OF THE RECEIVED DEVICE, IT WAS FOUND THAT PART OF THE INSULATION AROUND THE ASPIRATION HOLES WAS MELTED. THE DEVICE ALSO FAILED HIPOT TESTING AROUND THE MELTED INSULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6799264 ↗
• MalfunctionAug 16, 2017Failure to Fire; Failure to Fire

  THE CUSTOMER REPORTED THAT THE DEVICE WAS SPARKING. NO PATIENT INJURY OCCURRED AND A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. DURING MEDTRONIC'S INITIAL EVALUATION OF THE RECEIVED DEVICE, IT WAS FOUND THAT PART OF THE INSULATION AROUND THE ASPIRATION HOLES WAS MELTED. THE DEVICE ALSO FAILED HIPOT TESTING AROUND THE MELTED INSULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6799255 ↗
• MalfunctionAug 2, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE SPATULA TIP BROKE EASILY WITHOUT ANY TENSION APPLIED TO IT. THE PIECE FELL INTO THE CAVITY AND WAS RETRIEVED. A NEW DEVICE WAS USED TO CONTINUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6761451 ↗
• MalfunctionApr 26, 2017Melted; Melted

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, MIST WAS EMITTED FROM THE BLACK PART OF THE SHAFT AND FROM THE ASPIRATION HOLE. THE INSULATION AT THE PROXIMAL SEEMED BURNT. THE SHAFT WAS MELTED AND NO METALLIC MATERIAL WAS AROUND THE SPATULA. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT HARM. COVIDIEN'S INITIAL EVALUATION FOUND THE DEVICE FAILED HIPOT TESTING AROUND THE MELTED INSULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6523449 ↗
• MalfunctionApr 14, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THE DURING THE PROCEDURE THE SPATULA TIP BROKE AND FELL INTO THE PATIENT'S CAVITY. THE TIP WAS IMMEDIATELY REMOVED FROM THE PATIENT AND A NEW DEVICE WAS USED TO CONTINUE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6494594 ↗
• MalfunctionMar 28, 2017Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE CUSTOMER REPORTED THAT PRIOR TO THE START OF THE PROCEDURE WHILE PREPARING THE DEVICE, THE BLACK SHAFT OF THE ELECTRODE STARTED MOVING UPON CONNECTING WITH HANDLE AND THE ELECTRODE EVENTUALLY DISCONNECTED FROM THE HANDLE. A NEW ELECTRODE WAS OPENED TO CONTINUE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL ANALYSIS FOUND THE BLACK INSULATION ON THE TUBE AND THE MECHANICAL ASSEMBLY THAT CONTROLS THE INSULATION POSITION OVER ACTIVE ELECTRODE HAD COMPLETELY SEPARATED FROM THE REST OF THE ELECTRODE. THE INSULATION EASILY SLID UP THE ELECTRODE. THE INSULATION DID NOT DETACH FROM THE ELECTRODE HOWEVER THE BARE METAL OF THE ELECTRODE WAS EXPOSED. THE DEVICE FAILED HIPOT TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 6439531 ↗
• MalfunctionSep 6, 2016Energy Output Problem; Energy Output Problem

  THE CUSTOMER ORIGINALLY REPORTED THAT DURING A PROCTECTOMY, THE TIP OF THE DEVICE MELTED AND SPARKED. ANOTHER DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION AND THE AREA AROUND WHERE THE ELECTRODE MELTED FAILED HIPOT TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5928705 ↗